AnxietyPhase 2NCT02208726
The Effect of Picricum Acidum and Phosphoricum Acidum Homaccord on Perceived Levels of Anxiety in University Students
A Phase 2 study testing Sucrose pillules and Homeopathic homaccord in people with Anxiety, run by University of Johannesburg at 1 site in South Africa.
Trial summary
Increased levels of stress and anxiety are experienced by many students. Stress can have a negative influence on academic outcome and performance, as well as on the student's mental health. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Sucrose pillules and Homeopathic homaccord
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Africa
- Study dates
- Sep 2013to Aug 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, between the ages of 18 and 45;
- Registered University students;
- Participants must experience anxiety symptoms, manifesting six or more of the following criteria: muscle tension, increased perspiration, rapid heartbeat, headaches, stomach aches, agitation, irritability, hostility, fear, extreme sensitivity to rejection or failure, motor restlessness, procrastination, excessive worry, concentration difficulties, attention difficulties and memory problems;
- Participants must be writing a major examination one week after the study ends;
- Participants must have six or more of the symptoms relating to Picricum acidum and Phosphoricum acidum (Appendix D); and
- Participants must have a cell phone and on-line computer access.
Who cannot join
- Have been diagnosed with: A psychological anxiety disorder, Psychiatric disorders (Bipolar disorder, Depression), Attention Deficit Hyperactivity Disorder and Epilepsy.
- Are taking any chronic medication for anxiety or mood stabilizing
- Are pregnant or lactating
Trial locations and contacts
1 site in 1 country.
South Africa1 site
University of Johannesburg
Johannesburg, Gauteng, 2028
About this study
Increased levels of stress and anxiety are experienced by many students. Stress can have a negative influence on academic outcome and performance, as well as on the student's mental health. Conventional treatment options for anxiety include counseling, as well as anxiolytics and antidepressants, which may have various adverse effects. Picricum acidum and Phosphoricum acidum are homeopathic remedies that may be helpful in alleviating anxiety in students; however there has been no research done to date to show their efficacy for this condition.
The aim of this study is to determine the effect of Picricum acidum and Phosphoricum acidum Homaccord on perceived levels of anxiety in university students, by means of the State-Trait-Anxiety-Inventory and Anxiety Symptom Score Card.
Read the detailed description
This study will be a randomized, double-blind, placebo-controlled study, conducted over a two-week period at the University of Johannesburg (UJ) Health Clinic, Doornfontein Campus. Thirty university students, aged between 18 and 45 years, will be recruited into the study by means of advertisements placed on the campus with relevant permission given. Participants will attend an initial consultation and will be requested to sign a Participant Information and Consent form, complete the Participant Information Sheet, and a Remedy Symptom Questionnaire to determine inclusion into the study. Participants' vital signs will be measured. Participants will then receive a 16ml vial of either the Picricum acidum and Phosphoricum acidum Homaccord pillules, or a placebo (unmedicated sucrose pillules), which will be randomized and dispensed by the UJ Homeopathic Dispenser. Participants will be requested to take 5 pillules in a daily dose for 14 days, commencing 21 days before and ceasing 7 days prior to the start of examinations. The State-Trait-Anxiety-Inventory (STAI) and the Anxiety Symptom Score Card will be completed 21 days prior to the first academic examination, as well as on the last day of taking the medication. Data will be collected and analyzed by Statkon, using the Shapiro-Wilk test, the Mann-Whitney test and the Wilcoxon signed ranks test.
The outcome of this research may show that the Homeopathic Picricum acidum and Phosphoricum acidum Homaccord has a positive effect in alleviating anxiety in university students, allowing for further studies in the field.
- Conditions
- Anxiety
- Being tested
- Sucrose pillules, Homeopathic homaccord
- Keywords
- anxiety, students, examinations, Homeopathy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sucrose pillulesOther
Also called Saccharum officinale
Unmedicated sucrose pillules
Homeopathic homaccordOther
Also called Picricum acidum and Phosphoricum acidum homaccord
Sucrose pillules medicated with Picricum acidum and Phosphoricum acidum in potencies of 6CH, 30CH and 200CH.
| Study group | Role | What they receive |
|---|---|---|
| Sucrose pillules | Placebo comparator | Unmedicated sucrose pillules will be taken once daily, in the morning, 30 minutes after breakfast, for 14 days, up to 7 days before the first academic examination. Receives: Other: Sucrose pillules |
| Homeopathic homaccord | Experimental | Sucrose pillules medicated with Picricum acidum and Phosphoricum acidum in potencies of 6CH, 30CH and 200CH. Pillules will be taken once daily, in the morning, 30 minutes after breakfast, for 14 days, up to 7 days before the first academic examination. Receives: Other: Homeopathic homaccord |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait-Anxiety-Inventory
The State-Trait-Anxiety-Inventory is an established, acceptably reliable, validated and commonly utilized tool for measuring an individual's level of anxiety.
Measured: 14 days
Secondary outcomes (1)
Anxiety Symptom Score Card
The Anxiety Symptom Score Card is based on a 5-point grading scale and is designed to monitor anxiety-related symptoms.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startSep 2013
- Primary completionNov 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Johannesburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr J. Pellow, University of Johannesburg
- Investigators
- Janice Pellow, M.Tech Hom, Study director, University of Johannesburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208726
- Sponsor's protocol ID
- KaronWillson200731900
- Other IDs
- AEC44-01-2013
- Status last verified
- May 2016
- First submitted
- 4 Aug 2014
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Picricum Acidum and Phosphoricum Acidum Homaccord on Perceived Levels of Anxiety in University Students
- ClinicalTrials.gov ID
- NCT02208726
- Acronym / sponsor ID
- KaronWillson200731900
- Conditions
- Anxiety
- Keywords
- anxiety, students, examinations, Homeopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of JohannesburgUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 5 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Increased levels of stress and anxiety are experienced by many students. Stress can have a negative influence on academic outcome and performance, as well as on the student's mental health. Conventional treatment options for anxiety include counseling, as well as anxiolytics and antidepressants, which may have various adverse effects. Picricum acidum and Phosphoricum acidum are homeopathic remedies that may be helpful in alleviating anxiety in students; however there has been no research done to date to show their efficacy for this condition.
The aim of this study is to determine the effect of Picricum acidum and Phosphoricum acidum Homaccord on perceived levels of anxiety in university students, by means of the State-Trait-Anxiety-Inventory and Anxiety Symptom Score Card.
Detailed description
This study will be a randomized, double-blind, placebo-controlled study, conducted over a two-week period at the University of Johannesburg (UJ) Health Clinic, Doornfontein Campus. Thirty university students, aged between 18 and 45 years, will be recruited into the study by means of advertisements placed on the campus with relevant permission given. Participants will attend an initial consultation and will be requested to sign a Participant Information and Consent form, complete the Participant Information Sheet, and a Remedy Symptom Questionnaire to determine inclusion into the study. Participants' vital signs will be measured. Participants will then receive a 16ml vial of either the Picricum acidum and Phosphoricum acidum Homaccord pillules, or a placebo (unmedicated sucrose pillules), which will be randomized and dispensed by the UJ Homeopathic Dispenser. Participants will be requested to take 5 pillules in a daily dose for 14 days, commencing 21 days before and ceasing 7 days prior to the start of examinations. The State-Trait-Anxiety-Inventory (STAI) and the Anxiety Symptom Score Card will be completed 21 days prior to the first academic examination, as well as on the last day of taking the medication. Data will be collected and analyzed by Statkon, using the Shapiro-Wilk test, the Mann-Whitney test and the Wilcoxon signed ranks test.
The outcome of this research may show that the Homeopathic Picricum acidum and Phosphoricum acidum Homaccord has a positive effect in alleviating anxiety in university students, allowing for further studies in the field.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucrose pillules | Placebo comparator | Other: Sucrose pillulesUnmedicated sucrose pillules will be taken once daily, in the morning, 30 minutes after breakfast, for 14 days, up to 7 days before the first academic examination. |
| Homeopathic homaccord | Experimental | Other: Homeopathic homaccordSucrose pillules medicated with Picricum acidum and Phosphoricum acidum in potencies of 6CH, 30CH and 200CH. Pillules will be taken once daily, in the morning, 30 minutes after breakfast, for 14 days, up to 7 days before the first academic examination. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female, between the ages of 18 and 45;
- Registered University students;
- Participants must experience anxiety symptoms, manifesting six or more of the following criteria: muscle tension, increased perspiration, rapid heartbeat, headaches, stomach aches, agitation, irritability, hostility, fear, extreme sensitivity to rejection or failure, motor restlessness, procrastination, excessive worry, concentration difficulties, attention difficulties and memory problems;
- Participants must be writing a major examination one week after the study ends;
- Participants must have six or more of the symptoms relating to Picricum acidum and Phosphoricum acidum (Appendix D); and
Key exclusion criteria (3 listed)
- Have been diagnosed with: A psychological anxiety disorder, Psychiatric disorders (Bipolar disorder, Depression), Attention Deficit Hyperactivity Disorder and Epilepsy.
- Are taking any chronic medication for anxiety or mood stabilizing
- Are pregnant or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sucrose pillulesAlso: Saccharum officinaleUnmedicated sucrose pillules | Other | Sucrose pillules |
| Homeopathic homaccordAlso: Picricum acidum and Phosphoricum acidum homaccordSucrose pillules medicated with Picricum acidum and Phosphoricum acidum in potencies of 6CH, 30CH and 200CH. | Other | Homeopathic homaccord |
Primary outcome
State-Trait-Anxiety-Inventory
Time frame: 14 days
The State-Trait-Anxiety-Inventory is an established, acceptably reliable, validated and commonly utilized tool for measuring an individual's level of anxiety.
1 secondary outcome
Anxiety Symptom Score Card
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice Pellow, M.Tech Hom study director
University of Johannesburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sucrose pillules and Homeopathic homaccord in people with Anxiety, run by University of Johannesburg at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait-Anxiety-Inventory (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2016.